A Study to Investigate the Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency

Phase 3

Not yet recruiting

• Conditions: GHD
• Interventions: Drug: PEG-somatropin

• Registration Number: NCT06024967
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.

Detailed Description

The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.

Study Timeline

• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-29
• Status Verified: 2023-09
• Study First Posted: 2023-09-06
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-11
• Study Start: 2023-12-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Investigator-determined diagnosis of GHD prior to the historical initiation of daily rhGH trerapy
2. Participant must be 6 months to 17 years old
3. Tanner stage <5 at Visit 1
4. Open epiphyses
5. Normal fundoscopy at Screening
6. Written, signed, informed consent of the participant's parent(s)/LAR(s) and written assent of the participant

Exclusion Criteria

1. History or presence of malignant disease
2. Children with diabetes mellitus
3. Major medical conditions and/or presence of contraindications to GH treatment
4. Pregnancy
5. Participation in any other study of an investigational agent within three months prior to Visit 1
6. Prior exposure to investigational drug or any other long-acting growth hormone
7. Any other reason per investigator's discretion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GenSci004	PEG-somatropin	-

Primary Outcome Measures

Name	Time	Method
Adverse Events of once-weekly GenSci004 in children with GHD	108 weeks	Incidents of adverse events

Secondary Outcome Measures

Name	Time	Method
Annualized Height Velocity (AHV)	104 weeks	Measured in centimeter per year (cm/year)